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(DOX-oh-ROO-bih-sin)
Adriamycin RDF
Preservative-free solution for injection
2 mg/mL
Lyophilized powder for injection
10 mg, 20 mg, 50 mg, 100 mg, and 150 mg vials
Aqueous injection 2 mg/mL
5 mL, 10 mL, and 25 mL vials
Adriamycin PFS
Preservative-free solution for injection
2 mg/mL, 5 mL, 10 mL, 25 mL, and 100 mL vials
Aqueous injection 2 mg/mL
5 mL, 10 mL, and 25 mL vials
Rubex
Preservative-free solution for injection
2 mg/mL
Aqueous injection 2 mg/mL
5 mL, 10 mL, and 25 mL vials.
Class: Antineoplastic
Anthracycline antibiotic

 Actions Cells treated with doxorubicin have been shown to manifest the characteristic morphologic changes associated with apoptosis or programmed cell death. Doxorubicin-induced apoptosis may be an integral component of the cellular mechanism of action relating to therapeutic effects, toxicities, or both. The drug is rapidly distributed with about 75% binding to plasma proteins, principally albumin. There is greater free drug available in patients with a reduced hematocrit. The drug does not distribute into the CNS system.

 Indications

Adult

Leukemias, lymphomas, soft tissue and bone sarcomas; breast, ovarian, transitional cell bladder, thyroid, bronchogenic, and gastric carcinoma.

Children

Leukemias, lymphomas, Wilms tumor, neuroblastoma, bone sarcomas.

Refractory multiple myeloma; endometrial, islet cell, and lung carcinomas; AIDS-related Kaposi sarcoma.

 Contraindications Marked myelosuppression induced by previous treatment with other antitumor agents or by radiotherapy; a history of hypersensitivity reactions to conventional or liposomal doxorubicin or their components; previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, or other anthracyclines and anthracenes.

 Route/Dosage

Single Agent Therapy

ADULTS: IV 60 to 75 mg/m2 as a single dose q 21 days.

Alternative regimens are 30 mg/m2/day for 3 successive days q 4 wk; or 20 mg/m2 once weekly. Give the lower dose to patients with inadequate marrow reserves because of old age, prior therapy, or neoplastic marrow infiltration.

ADULTS: Intravesical Instill 50 mg in the bladder q 3 to 4 wk, retaining the solution in the bladder for 30 to 120 min.

CHILDREN: IV 35 to 75 mg/m2 IV, as a single dose q 21 days. Alternative regimens are 20 mg/m2 IV once weekly for 3 wk or 20 mg/m2/day IV for 3 successive days q 3 to 4 wk.

Combination Therapy

ADULTS: IV 40 to 60 mg/m2 as a single dose q 21 to 28 days. Give the lower dose to patients with inadequate marrow reserves because of old age, prior therapy, or neoplastic marrow infiltration.

Patients with Elevated Bilirubin

Dosage reduction: If serum bilirubin is 1.2 to 3 mg/dL, give 50% of adjusted dose from prior course. If serum bilirubin is 3.1 to 5 mg/dL, give 25% of adjusted dose from prior course.

Dosage Reduction in Hepatic Insufficiency

If serum bilirubin is 1.2 to 3 mg/dL, give 50% of adjusted dose from prior course. If serum bilirubin is above 3 mg/dL, give 25% of adjusted dose from prior course.

Lifetime Cumulative Doses Above Which Frequency of Cardiotoxicity Increases

ADULTS AND CHILDREN: IV No more than 500 mg/m2.

Adults and children who have received mediastinal radiation: IV No more than 400 mg/m2.

Adults above 70 yr with or without mediastinal radiation: IV No more than 300 mg/m2.

Interactions

Digoxin

Doxorubin may decrease oral absorption of digoxin tablets.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Acute arrhythmias; cardiomyopathy. DERMATOLOGIC: Alopecia; facial flushing; hyperpigmentation of nail beds and dermal creases; onycholysis; radiation recal; palmar-plantar erythrodysesthesia; urticaria; vein itching or streaking. GI: Nausea; vomiting; mucositis; necrotizing colitis. HEMATOLOGIC: Bone marrow suppression. HYPERSENSITIVITY: Anaphylaxis; cross-sensitivity to lincomycin. OTHER: Fever; chills.

 Precautions

Pregnancy: Category D. Lactation: Discontinue nursing. Children: Children are at increased risk for developing delayed cardiotoxicity. Doxorubicin may contribute to prepubertal growth failure. It also may contribute to gonadal impairment, which is usually temporary. Cardiac toxicity: Potentially fatal CHF may occur during therapy or months to years after termination of therapy. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 450 mg/m2. This toxicity may occur at lower cumulative doses in patients with prior mediastinal irradiation or on concurrent cyclophosphamide therapy or with preexisting heart disease. Pediatric patients are at increased risk for developing delayed cardiotoxicity. Elevated bilirubin: Some clinicians recommend not giving doxorubicin to patients with a bilirubin above 5 mg/dL. Extravasation risk: Local irritation of phelebitis may occur. Refer to the institution’s specific protocol. Myelosuppression: Severe myelosuppression may occur. Leukopenia is usually transient, reaching its nadir 10 to 14 days after treatment, with recovery usually by day 21. Expect white blood cell counts as low as 1000/mm3 during treatment. Necrotizing colitis: Manifested by typhlitis (eg, cecal inflammation, bloody stools, severe and sometimes fatal infections). Radiation: Radiation-induced toxicity to the myocardium, mucosa, skin, and liver have been increased.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Give by IV push injection or IV side arm into a running infusion.
  • Dilute the 10 mg vial with 5 mL, the 20 mg vial with 10 mL, the 50 mg vial with 25 mL, and the 150 mg vial with 75 mL of 0.9% Sodium Chloride for a final concentration of 2 mg/mL. Bacteriostatic diluents are not recommended.
  • Extravasation may occur with or without an accompanying burning or stinging sensation. Immediately terminate the injection or infusion and restart in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min qid for 3 days may be helpful.
  • Infusion reactions appear to occur with the first infusion and do not appear to occur with later infusions if not present initially. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction resolves by slowing the rate of infusion.
  • Phlebosclerosis may occur when small veins or a single vein is used for repeated administration; facial flushing may occur if injection is too rapid.
  • Incompatible with heparin, fluorouracil, cephalothin, and dexamethasone sodium phosphate.
  • A color change in doxorubicin from red to blue-purple, which denotes decomposition, occurs with aminophylline and 5-fluorouracil. Do not mix doxorubicin with other drugs.
  • Store lyophilized powder at room temperature and protect from sunlight.
  • Refrigerate preservative-free solution and protect from light.
  • Store Bedford aqueous injection in the refrigerator.
  • Reconstituted solution is stable for 7 days at room temperature (59° to 86°F) and under normal room light (100 foot-candles) and 15 days under refrigeration (2° to 8°C; 36° to 46°F). Protect from sunlight. Discard any of the unused solution from the 10, 20, and 50 mg single-dose vials. Discard unused solutions of the multiple-dose vial remaining beyond the recommended storage times.
  • For intravesical instillation in the bladder, doxorubicin may be diluted in 50 to 150 mL of sterile water or 0.9% Sodium Chloride.

IV infusion

  • Administer slowly into a freely running IV infusion of NaCl Injection or 5% Dextrose Injection. Attach tubing to a butterfly needle inserted into a large vein. Avoid veins over joints or in extremities with compromised venous or lymphatic drainage. Administer in at least 3 to 5 min. Local erythematous streaking along the vein as well as facial flushing may indicate too rapid administration.

 Assessment/Interventions

  • Initial treatment requires close patient observation and extensive laboratory monitoring. Hospitalize patients at least during the first phase of treatment. Initial treatment requires observation of the patient and periodic monitoring of CBCs, hepatic function tests, and radionuclide left ventricular ejection fraction.
  • Monitor ECG and systolic ejection fraction as the maximum cumulative lifetime dose approaches.
  • Assess hepatic function prior to therapy.
  • Doxorubicin may cause red discoloration of the urine for 1 to 2 days after administration.
  • Mucositis may occur 5 to 10 days after administration, leading to ulceration, and represent a site or origin for severe infections. Incidence and severity of mucositis is greater with the 3 successive daily dosage regimen. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections that can be fatal.
  • Administration of live vaccines to immunosuppressed patients may be hazardous.

Hyperuricemia

  • Monitor serum uric acid. Minimize effects of hyperuricemia with hydration, urinary alkalinization, and allopurinol.
OVERDOSAGE: SIGNS & SYMPTOMS
  Acute overdosage enhances the toxic effects of mucositis, leukopenia, pancytopenia, and thrombocytopenia. Chronic overdosage increases the risk of cardiomyopathy and resultant CHF.

 Patient/Family Education

  • Doxorubicin imparts a red color to the urine for 1 to 2 days after administration; advise patients to expect this during active therapy.
  • Explain name, action, and potential side effects of drug.
  • Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
  • Advise patient, family, or caregiver that medication may be used in combination with other agents to achieve maximum benefit possible.
  • Review dosing schedule with patient, family, or caregiver.
  • Advise patient, family, or caregiver that medication will usually cause a red coloration of the urine for 1 to 2 days after administration. Advise that this is not a problem and is expected because the medication is being eliminated in the urine.
  • Advise patient, family, or caregiver that medication may cause hair loss but that this is reversible when therapy is stopped.
  • Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; difficulty breathing; chest pain; fever, chills, or other signs of infection; sores in mouth; unusual bleeding or bruising; pain, redness, or swelling at injection site.
  • Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting, diarrhea or appetite loss; persistent or worsening general body weakness.
  • Instruct patient to not take any prescription or otc medications or dietary supplements unless advised by health care provider.
  • Caution women of childbearing potential to avoid becoming pregnant while being treated.
  • Instructwomen of childbearing potential to notify health care privder if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
  • Advise patient that following discharge from the hospital that frequent follow-up visits, ECGs, or heart function tests, and laboratory tests will be required to monitor therapy and to keep appointments.

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